FDA clears 5 upgrades for Lensar laser

The U.S. FDA has granted 510(k) clearance for five new application upgrades for the Lensar laser system. Collectively called the Streamline upgrades, they enable automation of several elements of surgical planning and execution, according to the company.

The upgrades include:

• Wireless integration with the Cassini corneal shape analyzer;
• Iris registration;
• Cataract density imaging;
• Customized fragmentation patterns; and
• Arcuate incision planning.

Streamline upgrades, including the arcuate incision planning, cataract density imaging and customized fragmentation patterns, will be made available to all Lensar users. The full Streamline technology suite will be available to practices currently using both the Lensar laser system and the Cassini corneal shape analyzer.

Lensar says this is the first femtosecond laser cataract platform to establish a wireless integration protocol with preoperative diagnostic devices. The company is initiating this capability with the Cassini corneal shape analyzer enabling the wireless transfer of data from preoperative corneal measurements to the Lensar laser system. This new integration eliminates potential errors that can occur from manual entry of data from the device used in the preoperative and surgical planning process. The integration with Cassini enables the capture of preoperative iris registration data and maps it to the image of the eye obtained under the laser at procedure time, eliminating the need to manually ink mark the eye to identify and adjust for the cyclorotation that may occur when a patient is reclined during surgery.

Additionally, surgeons have access to an arcuate incision planning table on the laser that includes parameters to define the location, depth and extent of the surgeon’s intended arcuate incisions based on individual patient biometric measurements and other factors defined by the surgeon. The arcuate incision planning capability allows surgeons to retain their plan preferences for later use, increasing surgical operating room efficiency.

The Streamline upgrades also introduce integrated cataract density imaging, which automatically categorizes the cataract to a pre-programmed, surgeon-customized fragmentation pattern depending upon the density of the cataract and allows the surgeon to automatically isolate fragmentation to the nucleus. Lensar believes this innovation may have a positive impact on efficiency and procedure time.

“Lensar has given the reigns to the surgeon to make the laser-assisted refractive cataract procedure customized to both patient and surgeon needs,” said Robert Weinstock, MD, director of cataract and refractive services at the Eye Institute of West Florida and The Weinstock Laser Eye Center. “The ability to preprogram the laser just one time with a surgeon’s specific preferences for fragmentation patterns based upon an automated cataract density analysis and customized arcuate incision plans may increase the efficiency and accuracy for every procedure thereafter, enhancing patient comfort and, ultimately, visual outcomes.”